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MS drug trial halted after failing to lower nerve damage

NCT ID NCT05630547

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an oral drug called SAR443820 in 174 adults with multiple sclerosis (MS) to see if it could lower a marker of nerve damage in the blood. The trial was stopped early because the drug did not meet its main goal of reducing that marker. Participants were followed for up to 96 weeks, but the study ended before completion.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

174 people

The number who actually took part.

Started

Dec 2022

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female, 18 to 60 years (inclusive) of age, at the time of signing the informed consent. * Participants with diagnosis of RRMS, SPMS (relapsing or non-relapsing) or primary progressive subtype according to the 2017 revision of the McDonald diagnostic criteria (SPMS diagnostic criteria according to initial relapsing remitting disease course followed by progression with or without occasional relapses, minor remissions, and plateaus; progression denotes the continuous worsening of neurological impairment over at least 6 months). * Participants with Expanded Disability Status Scale (EDSS) score of 2 to 6 inclusive at screening. * Participants who were either untreated or in the opinion of the Investigator were stable on an allowed disease-modifying therapy (DMT) (interferons, glatiramer acetate, fumarates, or teriflunomide) for at least the past 3 months, AND not anticipated to require a change in multiple sclerosis (MS) treatment for the duration of Part A and Part B (through Week 96); in Part B changes in dose of allowed DMTs or transition to other allowed DMTs was permitted). * Participants with body weight at least 45 kg and body mass index (BMI) at least 18.0 kg/m\^2. * Contraceptive use by men and women was consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: * Participants with immunodeficiency syndromes or other autoimmune diseases requiring immunosuppressive therapy * Participants with a history of seizures or epilepsy (history of febrile seizure during childhood was allowed). * Participants with known clinical relapse (acute or subacute episodes of new or increasing neurological dysfunction followed by full or partial recovery, in absence of fever or infection) within 8 weeks of screening. * Participants with neurological disease history other than MS, eg, head trauma within 3 months, cerebrovascular disease, and vascular dementia. * Participants with a history of recent serious infection (eg, pneumonia, septicemia) within 4 weeks of screening; an infection requiring hospitalization or intravenous antibiotics, antivirals, or antifungals within 4 weeks of screening; or chronic bacterial infections (such as tuberculosis) deemed unacceptable, as per Investigator's judgment. * Participants who had significant cognitive impairment, psychiatric disease, other neurodegenerative disorders (eg, Parkinson disease or Alzheimer disease), substance abuse, or any other conditions that made the participants unsuitable for participating in the study or interfered with assessment or completing the study in the opinion of the Investigator. * Participants with a documented history of attempted suicide over the 24 weeks prior to the Screening Visit, presents with suicidal ideation of category 4 or 5 on the Columbia Suicide Severity Rating Scale (CSSRS), or if in the Investigator's judgment, the participant was at risk for a suicide attempt. * Participants with a history of unstable or severe cardiac, pulmonary, oncological, hepatic, or renal disease or another medically significant illness other than MS precluding their safe participation in this study. * Participants who received a live vaccine within 14 days before the Screening Visit. * Participants with a known history of allergy to any ingredients of SAR443820 (mannitol, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and microcrystalline cellulose). * Participants who used any medications that are moderate or strong inhibitors or strong inducers of cytochrome P450 3A4 (CYP3A4). * Participants who used of any of the following medications/treatments: fampridine/dalfampridine, ofatumumab, fingolimod, cladribine, siponimod, ponesimod, ozanimod, alemtuzumab, mitoxantrone, ocrelizumab, natalizumab, or similar approved compounds but with different trade names and any unapproved treatments or therapies for MS; any DMTs newly approved after January 2023 that are marketed at any time during the course of the double-blind study period. These medications were not allowed within 5 half-lives before the Screening Visit and for the duration of Part A and Part B. * Participants who had prior/concurrent clinical study enrollment, ie, the participant had taken other investigational drugs within 4 weeks or 5 half-lives, whichever was longer, before the first Screening Visit; concurrent or recent participation in non-interventional studies may be permitted. Participants with abnormal laboratory test(s) at the Screening Visit: * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3.0 x upper limit of normal (ULN) * Bilirubin more than 1.5 x ULN; unless the participant has documented Gilbert syndrome (isolated bilirubin more than 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%) * Serum albumin less than 3.5 g/dL * Estimated Glomerular filtration rate less than 60 mL/min/1.73 m\^2 (Modification of Diet in Renal Disease \[MDRD\]) * Other abnormal laboratory values or electrocardiogram (ECG) changes that are deemed clinically significant as per Investigator's judgment * The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

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Conditions

The condition(s) this trial relates to.

multiple sclerosis primary progressive multiple sclerosis relapsing-remitting multiple sclerosis secondary progressive multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • Investigational Site Number : 0560001

    Brussels, BE-1200, Belgium

  • Investigational Site Number : 0560002

    Ghent, 9000, Belgium

  • Investigational Site Number : 0560003

    Overpelt, 3900, Belgium

  • Investigational Site Number : 1000001

    Sofia, 1407, Bulgaria

  • Investigational Site Number : 1000002

    Sofia, 1431, Bulgaria

  • Investigational Site Number : 1000003

    Sofia, 1680, Bulgaria

  • Investigational Site Number : 1240001

    Gatineau, Quebec, J8Y 1W2, Canada

  • Investigational Site Number : 1240002

    Ottawa, Ontario, K1H 8L6, Canada

  • Investigational Site Number : 1240003

    Lévis, Quebec, G6W0M5, Canada

  • Investigational Site Number : 1240004

    Toronto, Ontario, M5B 1W8, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8380456, Chile

  • Investigational Site Number : 1560001

    Tianjin, 300052, China

  • Investigational Site Number : 1560002

    Shanghai, 200040, China

  • Investigational Site Number : 1560003

    Chengdu, 610041, China

  • Investigational Site Number : 1560004

    Xi'an, 710038, China

  • Investigational Site Number : 2500001

    Paris, 75013, France

  • Investigational Site Number : 2500002

    Nice, 06001, France

  • Investigational Site Number : 2500003

    Strasbourg, 67098, France

  • Investigational Site Number : 2500004

    Caen, 14033, France

  • Investigational Site Number : 2760002

    Würzburg, 97074, Germany

  • Investigational Site Number : 3800001

    Pozzilli, Isernia, 86077, Italy

  • Investigational Site Number : 3800002

    Milan, 20132, Italy

  • Investigational Site Number : 3800003

    Milan, 20133, Italy

  • Investigational Site Number : 3800005

    Cagliari, 09126, Italy

  • Investigational Site Number : 6160001

    Krakow, 31-503, Poland

  • Investigational Site Number : 6160002

    Katowice, Silesian Voivodeship, 40-571, Poland

  • Investigational Site Number : 6160004

    Plewiska, Greater Poland Voivodeship, 62-064, Poland

  • Investigational Site Number : 6160005

    Katowice, Silesian Voivodeship, 40-686, Poland

  • Investigational Site Number : 6160006

    Zabrze, 41-800, Poland

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240002

    Seville, Andalusia, 41009, Spain

  • Investigational Site Number : 7240003

    Madrid, Madrid, Comunidad de, 28040, Spain

  • Investigational Site Number : 7240004

    Madrid / Madrid, Madrid, Comunidad de, 28007, Spain

  • Investigational Site Number : 7240005

    Murcia, 30120, Spain

  • Investigational Site Number : 7240006

    Madrid, 28034, Spain

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